Preventable Disease, VaccineNCT04567342

Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination

A study testing 1 automated message, 2 automated messages and No personal contact attempt in people with Preventable Disease, Vaccine and Health Care Utilization, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment… Read more about this study

Who is it for?: Ages 12 months to 4 years
Conditions the study is for: Preventable Disease, Vaccine, Health Care Utilization
What is being tested?: 1 automated message, 2 automated messages and No personal contact attempt
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,312 participants
Where: 1 siteUnited States
Study dates: 27 Nov 2020to 5 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age: 12-14 months old OR 4 years old
Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds)
Has not had a well child check in past 365 days (for 4 year olds)
No appointment scheduled in the next 45 days
Parent preferred language = English or Spanish

Who cannot join

Phone number not available in electronic medical record

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039

Other trials in United States

About this study

Conditions: Preventable Disease, Vaccine, Health Care Utilization
Being tested: 1 automated message, 2 automated messages, No personal contact attempt, 1 personal contact attempt
Medical subject headings: Vaccine-Preventable Diseases, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1 automated messageOther
Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.
2 automated messagesOther
Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.
No personal contact attemptOther
No personal contact attempts will be made.
1 personal contact attemptOther
Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment.

Study groups in NCT04567342
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Other: 1 automated message; Other: No personal contact attempt
Arm 2	Experimental	Not described Receives: Other: 2 automated messages; Other: No personal contact attempt
Arm 3	Experimental	Not described Receives: Other: 1 automated message; Other: 1 personal contact attempt
Arm 4	Experimental	Not described Receives: Other: 2 automated messages; Other: 1 personal contact attempt

What is being measured

The primary outcome is the main question the study is designed to answer.

Receipt of MMR Vaccination
MMR administered to child (Yes or No) based on electronic health record documentation
Measured: By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old)

Secondary outcomes (2)

Appointment Scheduled
Appointment scheduled (Yes or No) based on electronic health record documentation
Measured: Within 2 weeks of receiving intervention
Appointment Completed
Appointment completed (Yes or No) based on electronic health record documentation
Measured: Within 8 weeks of receiving intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 20205 Sep 2021

First posted28 Sep 2020
Study start27 Nov 2020
Primary completion6 Aug 2021
Study completion5 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Preventable Disease, VaccineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04567342
Sponsor's protocol ID: 2020-0769
Status last verified: Aug 2024
First submitted: 23 Sep 2020
Last updated: 12 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
ClinicalTrials.gov ID: NCT04567342
Acronym / sponsor ID: 2020-0769
Conditions: Preventable Disease, Vaccine, Health Care Utilization
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,312 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: 27 Nov 2020 (actual)
Primary completion: 6 Aug 2021 (actual)
Study completion: 5 Sep 2021 (actual)
First posted: 28 Sep 2020 (actual)
Results: Posted 12 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Arm 1	Experimental	Other: 1 automated message, Other: No personal contact attempt
Arm 2	Experimental	Other: 2 automated messages, Other: No personal contact attempt
Arm 3	Experimental	Other: 1 automated message, Other: 1 personal contact attempt
Arm 4	Experimental	Other: 2 automated messages, Other: 1 personal contact attempt

Who may qualify

Ages: 12 months to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Age: 12-14 months old OR 4 years old
Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds)
Has not had a well child check in past 365 days (for 4 year olds)
No appointment scheduled in the next 45 days
Parent preferred language = English or Spanish

Key exclusion criteria (1 listed)

Phone number not available in electronic medical record

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1 automated messageParents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.	Other	Arm 1, Arm 3
2 automated messagesParents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.	Other	Arm 2, Arm 4
No personal contact attemptNo personal contact attempts will be made.	Other	Arm 1, Arm 2
1 personal contact attemptParents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment.	Other	Arm 3, Arm 4

Primary outcome

Receipt of MMR Vaccination
Time frame: By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old)
MMR administered to child (Yes or No) based on electronic health record documentation

2 secondary outcomes

Appointment Scheduled
Time frame: Within 2 weeks of receiving intervention
Appointment Completed
Time frame: Within 8 weeks of receiving intervention

Results and safety

Results posted to the registry on 12 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	329	329
Arm 2	328	328
Arm 3	328	328
Arm 4	327	327

Primary outcome: Receipt of MMR Vaccination

Time frame: By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old). Count of participants. Unit: Participants

Measure	Arm 1 n = 329	Arm 2 n = 328	Arm 3 n = 328	Arm 4 n = 327
Value	92	77	99	104

Arm 1 vs Arm 3: Risk Ratio (RR): 1.08 (95% CI 0.85 to 1.37), p = 0.531, Regression, Logistic
Arm 1 vs Arm 2: Risk Ratio (RR): 0.84 (95% CI 0.65 to 1.09), p = 0.189, Regression, Logistic
Arm 2 vs Arm 3: Risk Ratio (RR): 1.29 (95% CI 0.10 to 1.66), p = 0.054, Regression, Logistic

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 329 (0%)	0 of 329 (0%)	0 of 329
Arm 2	0 of 328 (0%)	0 of 328 (0%)	0 of 328
Arm 3	0 of 328 (0%)	0 of 328 (0%)	0 of 328
Arm 4	0 of 327 (0%)	0 of 327 (0%)	0 of 327

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William B Brinkman, MD study director

Cincinnati Children's

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receipt of MMR Vaccination (time frame: By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04567342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.